Public Health and National Security Planning: The Case forVoluntary Smallpox Vaccination

Vaccinating the American public against
smallpox is no longer just a public health issue. In light of a
possible war with Iraq and recent statements attributed to al-Qaeda
leader Osama bin Laden, it has become a national security matter.
Mounting concerns about new terrorist attacks, including biological
attacks on American civilians, have intensified the debate among
policymakers and public health officials over how best to prepare
for a smallpox attack, either with preemptive or post-attack
vaccinations. Even a localized attack on non-immunized Americans
could result in the deaths of a million or more people
nationally.1 A
comprehensive strategy is needed.

To
protect Americans in the nearest possible term from such terrorism,
the federal government should:

Carry
through on plans to vaccinate essential military personnel
immediately;

Urge
states to vaccinate all first responders and public health
officials essential to their state and local response plans;
and

Make
the vaccine available to the general public for voluntary
inoculations following a broad campaign of education.

From
a national security perspective, preemptive but voluntary smallpox
vaccinations for the general public--along with a more
comprehensive vaccination program for military personnel and
critical first responders--makes the most sense. Voluntary
vaccinations would help reduce the spread of the disease were it
used as a weapon, improve the ability of the public health sector
to treat those infected from an attack, reduce panic during a
crisis, and provide a reasonable deterrent to the use of smallpox
by terrorists.

While the vaccine does pose some risks,
these are offset by the growing threat and the government's
responsibility to ensure Americans' well-being. Moreover, compared
with a mandatory vaccination regime, a voluntary vaccination
program would respect an individual's right to choose whether or
not to absorb the risks of inoculation.

Assessing the Risks

Smallpox is an extremely contagious
disease once a victim begins to show symptoms--usually seven to 17
days after exposure. Historically, it has a fatality rate of
approximately 30 percent. An attack against an unprotected
population, therefore, could spread rapidly and have dire
consequences. However, statistics also predict that, absent an
attack, approximately 300 people would die in a mass inoculation
program.2

Knowing this, policymakers must decide
whether to vaccinate everyone before an attack or wait until after
an attack to begin the vaccinations. While some officials are
considering a mandatory inoculation program, a voluntary preemptive
program that respects the right of each person to decide whether to
absorb the risk associated with the vaccine rather than the risk of
contracting smallpox would be far more effective. It would promote
national preparedness by reducing the numbers that would need to be
vaccinated should an attack occur and also address important
liability concerns that could discourage the vaccine's
manufacturers.

The Use of Smallpox as Bioweapon

In
1980, the World Health Organization (WHO) declared that smallpox
had been eradicated as a naturally occurring disease, with the last
known case having occurred in Somalia in 1977.3 Currently, there are only two
WHO-approved and inspected repositories of the live virus: the
Centers for Disease Control and Prevention (CDC) in Atlanta and
Vector Laboratories in Russia. All other nations holding stores of
the virus were directed to destroy them or send them to one of
these facilitates.

Nevertheless, clandestine stockpiles are
believed to exist in states such as Iraq and Iran that have
worrisome ties to terrorist organizations.4 Further, the former Soviet Union is
suspected of experimenting with weaponizing the smallpox virus
during the 1980s in violation of international agreements.5 While those stocks are
believed to have been destroyed, experience has shown that Soviet
(and early post-Soviet Russian) security at its weapons of mass
destruction (WMD) research and storage facilities was questionable
at best; stocks of the virus could have been smuggled out.6 As a result, it is
very difficult to determine the extent of the threat today.

U.S. Vulnerability

Though the likelihood of a smallpox attack
and the merits of different vaccination strategies are certainly
open to debate, the potential consequences of an attack and the
vulnerability of the U.S. population to an outbreak are not.
American civilians have not been vaccinated against smallpox since
1972, and the Department of Defense stopped vaccinating troops in
the 1980s (a new military vaccination program is being reviewed by
the White House). As a result, those under 30 years of
age--approximately 42 percent of the American population7--are not likely to
have been vaccinated; they would be highly susceptible to
contracting smallpox in the event of an attack.

Added to this concern is the fact that it
is not known whether those vaccinated before 1972 retain any
immunity to the disease. The lack of immunity would make the
general population grossly vulnerable to the disease.

Hazards Associated with the Smallpox
Vaccine

The
smallpox vaccine also carries significant risks. Experience with
the vaccination program in the United States prior to 1972
indicates that approximately one in every 1 million first-time
recipients is likely to die from complications.8 Therefore, a complete vaccination of
the U.S. population could cost 300 lives. Estimates of how many
people would suffer from serious complications but not die vary
dramatically from one in every 8,000 to one in every 67,000.9

Opponents of vaccinating the general
population in advance of an attack include the American Medical
Association and other groups in the medical community. They
typically cite two reasons for their opposition: the unknown nature
of the threat and the risks associated with the vaccine. The logic
behind their decision is twofold: (1) a belief that, without a
better assessment of the threat, the potential loss of life (even
if only a tiny fraction of the population) outweighs the benefits
of vaccination and (2) concerns over the legal liability of the
administering physicians as the distributors of the vaccine. They
suggest limiting pre-incident vaccination to the military and those
first responders who choose to receive it. The general population
would be left vulnerable and would not receive treatment until
after an attack.

But
ignoring national security concerns and choosing a vaccination
strategy based merely on public health concerns would leave the
United States defenseless against an attack. Terrorists such as
al-Qaeda operatives will look for any deficiencies in domestic
preparedness and take advantage of them.

The CDC's Flawed Post-Attack
Approach:
The Limits of Ring Vaccination

Since the terrorist and anthrax attacks of
2001, the CDC and its parent agency, the U.S. Department of Health
and Human Services, have undertaken significant efforts to ensure
that by the end of this year, there will be enough smallpox vaccine
available to inoculate every American. The policy procedure for
implementing this objective is developing more slowly.

Initially, the CDC planned to rely only on
a strategy known as ring vaccination, which helped to eliminate the
natural occurrence of smallpox in the 1960s and 1970s. This
strategy relies on tracking down all those who came into contact
with the initial case (or cases) and vaccinating them within four
days of the initial exposure.

Such
an approach is poorly suited to combating a terrorist attack using
smallpox, since hundreds or thousands of people would be infected
during the initial release of the virus. In America's highly mobile
society, those initially infected are likely to spread the disease
over a very wide geographic area. Tracking down all those who have
had contact with the original infected group would be a huge
undertaking. Yale University Professor Edward Kaplan is among those
who are pessimistic about using the ring vaccination strategy.
Concerning the CDC plan, he said it would be "a fantasy to believe
that the control of small natural outbreaks provides guidance for
large bioterrorist attacks."10

Further, much of the vital four-day window
in which post-exposure vaccination is known to be effective in
preventing illness would be absorbed by logistics. As recently as
June of this year, the CDC's Advisory Committee on Immunization
Practices (ACIP), which developed the ring smallpox vaccination
strategy, noted that only one lab in the nation (the CDC in
Atlanta) is capable of confirming a case of smallpox and that such
a determination can take between eight and 24 hours.11 Moreover, it will
take 12 to 24 hours for the vaccine in the National Pharmaceutical
Stockpile to reach its distribution points.12 Even if a first-generation case was
sent promptly to the CDC in Atlanta for review, much of that
crucial four-day vaccination window would be lost, and the ability
to prevent the onslaught of second-generation cases would be less
certain.

The Challenge of Mass Vaccinations After
an Attack

The
CDC recently revised its strategy, noting that it may need to
undertake regional or national voluntary mass vaccinations in the
event of an attack.13
In fact, the ACIP noted that the ring vaccination strategy would
need to be supplemented occasionally by post-incident voluntary
vaccinations during large outbreaks in order to eradicate the
disease.14 The CDC
recognizes that terrorists will likely target large numbers of
people. It is planning to allow first responders and public health
workers to receive the vaccine on a voluntary basis, and it has
reserved 1 million doses for the Defense Department's draft
vaccination program.

Making the smallpox vaccine available to
those who will be instrumental in combating an outbreak and those
responsible for fighting the international war on terrorism is a
good first step. But CDC's reluctance to undertake mass
vaccinations in advance of an attack is a mistake.15 CDC's calculation
fails to consider that, after a confirmed smallpox attack, the
health officials would have to vaccinate at least a portion of the
population in a crisis.

As
the nation saw during the anthrax attack, in a crisis, people are
likely to demand access to treatment whether they have been exposed
to an agent or not. Since smallpox historically has proven a much
more deadly disease than anthrax, fear during a smallpox attack may
prove much greater than anything witnessed last fall. Not only
would the crisis environment present challenges and risks in
distribution of the vaccine, but all of the risks associated with
the vaccine also could be amplified. The need for quick action
would not leave sufficient time for screening patients who are at
risk for complications or allow medical professionals to focus
adequately on follow-up care.

The
CDC has published guidelines recommending how local public health
officials should handle these complications.16 But while this is an important step in
ensuring a well-managed response, it leaves the locality to decide
for itself how best to handle security.17The additional challenges of
inoculating people during a crisis would be greatly reduced through
a system of voluntary vaccination.

The Value of Voluntary Vaccination for
National Defense

After a smallpox attack, the difficulties
associated with the ring vaccination program or CDC's crisis
management approach to mass vaccinations could be greatly reduced
if even a portion of those in the target area did not need to be
vaccinated. Ensuring some degree of prior immunity among the
population at large through preemptive and voluntary vaccinations
would boost the public health sector's ability to stop the spread
of the disease, since fewer people would be likely to contract and
spread it. This also would mitigate the national (and potentially
international) consequences of an attack.

Moreover, a voluntary vaccination program
implemented during a non-crisis time would enable doctors to take
more exacting measures. They would be better able to screen out
patients at high risk for complications from the vaccine--for
example, people with weakened immune systems or a history of skin
problems, pregnant women, or children under one year of age. With
the number of people who need vaccinations after an attack reduced,
the risk of chaos also would fall, with fewer people rushing to
hospitals to be treated, and the availability of adequate
outpatient and follow-up care would rise.

A Plan for Action

The
CDC should begin developing standards for voluntary vaccinations
with the intent of instituting that strategy early in the new year
instead of focusing on how to vaccinate potentially millions of
Americans after an attack. The CDC also should begin drafting a set
of guidelines for distributing the vaccine to hospitals nationwide
and for screening out prospective recipients at high risk of
experiencing complications. And it should begin drafting standards
for post-procedure care to reduce the likelihood of complications
or further transmission.

The
CDC also should develop an educational program on the risks
associated with smallpox and the vaccine. This program should not
encourage or discourage vaccination, but simply lay out the facts
clearly so that each American can make an educated decision. The
administering physicians should inform potential recipients of the
risks involved, consistent with CDC's guidelines, and those who
agree to the inoculation should sign a waiver noting that they
understand the risks and accept responsibility for potential side
effects.

Beyond these guidelines, the federal
government should leave ultimate responsibility for the details of
the distribution program with state and local authorities.

Inoculating Frontline Military
Personnel

The
Department of Defense reportedly plans to vaccinate approximately
500,000 of its 1.4 million active duty personnel, beginning with
medical staff and followed by those troops likely to be deployed to
the Middle East.18
Procedures for immunizing these frontline troops should continue as
planned. The Defense Department should also plan to expand this
program to vital National Guard personnel who would likely be
called upon to assist civil authorities during a domestic smallpox
attack.

Vaccinating First Responders

Consideration must also be given to the
fact that vulnerability among the nation's first responders
directly affects the country's ability to respond to an attack.
These professionals are likely to find themselves in close and more
frequent contact with infected people in the event of attack. Every
community, therefore, will need to have some first responders,
particularly health care workers, who are immune to the disease
already and can operate in an environment where the virus is
abundant (such as secure areas of a hospital or other locations
dedicated to the care of smallpox victims). But many first
responder jobs will also be required in lower-risk areas.
Consequently, a federally mandated, universal program for
vaccinating all first responders, while beneficial, may not be
necessary.

Vaccination standards for first responders
should therefore be left up to state and local agencies. The
federal government should encourage the states and communities to
vaccinate personnel deemed essential to the community's smallpox
response plan, but it should allow the local authorities to
determine who those personnel are and how to implement the
vaccination requirement. First responders who are not essential to
a community's smallpox response plan could participate in a
voluntary program; they should not be required to be immunized as a
condition of their first-responder position.

Dealing with Liability Concerns

The
federal government should take action now to address the potential
liability concerns of a vaccination program, but it should not
assume responsibility for health decisions made by individuals.
Public education will be crucial not only to reducing America's
susceptibility to a smallpox attack, but also to addressing the
liability concerns properly.

The
Food and Drug Administration (FDA) has never approved the current
supply of smallpox vaccine. Though the vaccine's risks and benefits
are well-documented from its long use prior to 1972, it is
currently being distributed under Investigational New Drug (IND)
protocols designed to determine whether it is reasonably safe for
initial use in humans. Nonetheless, in a nation where trial
attorneys view litigation as a mechanism for social activism, it is
likely that financial compensation will be sought by some of those
who accept the vaccine and later become ill or by families of the
small number of people who die as a result of complications. In a
voluntary vaccination program that includes pretreatment education
about the known risks and the degree of uncertainty of outcome,
primary responsibility for the decision to take advantage of the
smallpox vaccine should lie with the individuals who seek it.

Admittedly, administering physicians
should be required to educate each individual about the vaccine's
risks and take every reasonable precaution to screen out those who
are particularly vulnerable. And medical professionals should be
held liable for gross negligence in the process of educating,
screening, administering vaccines, or providing outpatient care.
The federal government should enforce guidelines related to the
program, but the government, hospitals, doctors, and companies that
manufacture the vaccine should not be held liable for the vaccine's
known or well-established risks in a voluntary program that
publicizes those risks. Congress should ensure that developers of
vaccines and the administering doctors have protection from
liability in this regard.

Governor Tom Ridge, the Secretary of
Homeland Security designee, reportedly prefers to address liability
concerns with a system that would compensate those who suffer from
any complications. While this approach could be modeled on elements
of the National Vaccine Injury Compensation Program,19 that program is
designed to compensate those who suffer complications from
childhood vaccines related to active and known diseases in the
population today. Many of these vaccinations are now required
before a child can enter public school. To receive compensation, a
patient must prove that the illness is the result of a vaccination,
and compensation is limited.20 Limiting payments is better than
allowing unfettered legal action, but little else about this
program applies to a smallpox terrorist attack or mass vaccination
program.

Smallpox is not a known disease, and
inoculating the entire population to avert the effects of a feared
terrorist attack would expose far more people to the possibility of
complications than do the current inoculations for other known
diseases. A voluntary program using vaccines with well-established
risks that allows each person to decide whether to expose himself
or herself to those risks or remain at risk of contracting the
disease itself in a bioterrorist attack is a better approach. To
defer some of the potential costs of adverse reactions to the
vaccine, people who choose the inoculation should seek health
insurance to cover that risk.

To
protect suppliers of future vaccines, the Secretary of Homeland
Security should designate all existing formulas of the smallpox
vaccine as "qualified antiterrorism technologies" under the Support
Anti-Terrorism by Fostering Effective Technologies Act of 2002 (the
SAFETY Act).21 The
act allows the Secretary of Homeland Security to limit damages that
a plaintiff can seek against the producer of a designated
antiterrorism technology.

To
be designated as a qualified antiterrorism technology, the vaccine
must meet seven criteria: prior use by the federal government or
demonstrated utility and effectiveness; availability for immediate
deployment; potentially large or unquantifiable liability risk;
likelihood that it will not be deployed unless protected; risk if
not deployed; other means of reducing risk have been studied; and
it is effective in defending against terrorism. A vaccine to
protect the general population from a particularly dangerous agent
such as smallpox is a good candidate for the qualified
antiterrorism technology designation.

A
completely vaccinated population, of course, would offer the United
States strategic immunity from smallpox attacks. Vice President
Richard Cheney reportedly favors this approach, and the President
is currently weighing this option.22 While the federal government could
mandate a nationwide smallpox vaccination program on the grounds
that is in the national security interest of the United States,
absent a known threat, such action is probably unnecessary and
could raise complicated liability question.

The Best Approach to Vaccinating America
Against Smallpox

The
federal government's responsibility rests in developing a
vaccination program that protects the security and safety of the
nation. The CDC expects to have enough vaccine for every American
by the end of 2003. Combined with a well-prepared public health
sector and a clear post-incident vaccination strategy, a voluntary
preemptive vaccination program would mitigate the consequences of a
terrorist attack by limiting the spread of the disease and reducing
panic without trampling on the freedom of Americans to decide for
themselves how best to protect themselves and their families. There
are significant risks with the smallpox vaccine, but the risk of
bioterrorism is rising, and Americans should be allowed to weigh
all those risks as they relate to their own safety.

As
the Administration develops its policies for combating domestic
terrorism, a comprehensive plan for a potential smallpox attack
against the United States should seek to:

Vaccinate
frontline military personnel essential to the war on terrorism
immediately. The President should approve the Defense
Department's plan to begin vaccinating active duty medical
personnel and troops who are to be deployed to the Middle East.
Then it should begin to vaccinate National Guard personnel who are
essential to state or national bioterrorism preparedness
plans.

Urge state and
local authorities to require vaccinations of critical first
responders. The CDC already has mandated that communities
develop response plans for a potential smallpox attack. The states
should be urged to require vaccination for critical first
responders, including public health officials, who are deemed
essential to implementing such plans. First responders not at risk
of exposure in an attack should be encouraged, but not required, to
participate in a voluntary vaccination program.

Make the vaccine
available to the general public for voluntary inoculations
following a broad campaign of education. By the end of the
year, the CDC plans to have enough vaccine to inoculate the entire
U.S. population. While there are significant risks associated with
the existing stock of smallpox vaccine, the CDC should begin
developing plans to educate the medical community and the general
public on the benefits and risks of vaccination and the threat of
terrorism. Then it should implement a policy that allows
individuals to receive the vaccine on a voluntary basis after
signing a consent form. Such a program would improve overall
national preparedness, likely reduce panic in the event of an
attack, address a number of crucial liability issues, and respect
the freedom of Americans to determine with their doctor how best to
meet their own health and security needs.

Conclusion

From
a national security perspective, a preemptive but voluntary
smallpox vaccination program for the general public in addition to
a more comprehensive vaccination of military personnel and first
responders makes sense. Preemptive vaccinations administered in
this manner would reduce the spread of the disease, improve the
public health sector's ability to treat those at risk or infected
after an attack, reduce panic and potential chaos during a crisis,
and provide a reasonable deterrent to the use of smallpox by
terrorists.

While the vaccine does pose some risk to
Americans, these risks are offset by the growing threat of a
smallpox attack and the government's need to protect the nation and
the well-being of the population at large. In contrast to a
mandatory vaccination regime, a voluntary vaccination program also
respects an individual's right to choose.

--Michael
Scardaville is Policy Analyst for Homeland Security in the
Kathryn and Shelby Cullom Davis Institute for International Studies
at The Heritage Foundation.

1.Estimate based on
scenarios such as the "Dark Winter" war game conducted in June 2001
by the Johns Hopkins Center for Civilian Biodefense, Anser
Institute for Homeland Security, Center for Strategic and
International Studies, and Oklahoma City National Memorial. See
http://www.hopkins-biodefense.org/DARK%20WINTER.pdf.

2.Donald G. McNeil, Jr.,
and Lawrence K. Altman, "Next Step in Smallpox Effort: Drug for
Vaccine Side Effects," The New York Times, November 12, 2002.

3.Centers for Disease
Control and Prevention, "Smallpox Surveillance--Worldwide," October
24, 1997, at
http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00049694.htm.

19.See, for example,
Veronique de Rugy and Charles V. Pena, "Responding to the Threat of
Smallpox Bioterrorism: An Ounce of Prevention Is Best Approach,"
Cato Institute Policy Analysis, April 18, 2002, pp. 11-12. That
program was created under the National Childhood Vaccine Act of
1986 (P.L. 99-660).

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Preemptive but voluntary smallpox vaccinations for the generalpublic is the best way to respond to the growing threat ofterrorist biological attack. The growing threat offsets the risk ofthe vaccine, and a voluntary vaccination program preserves anindividual's right to choose whether to risk inoculation.

Rep. Peter Roskam (R-IL) says it's "a great way to start the day for any conservative who wants to get America back on track."

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